This document describes an eLearning management system called webTraining designed for pharmaceutical companies and quality-focused organizations. Some key features include being 100% web-based and accessible from anywhere, fully compliant with 21 CFR Part 11 regulations, able to integrate with electronic document management systems and manufacturing execution systems, and offering comprehensive training management functionality such as needs assessment, planning, delivery, monitoring, and reporting across multiple international sites from a single centralized installation. The system aims to simplify training processes and documentation while ensuring regulatory compliance.
2. designed thinking to the world
ItalySpain
UK
Germany
SwitzerlandBelgiumUSA
India
Brazil
100% web
based
can be used from
anywhere, using a
simple, last generation
multi-language
accessible by each
user in his/her own
language (Unicode
support)
centralized installation
system easy to manage and
update, while guaranteeing
maximum autonomy to each
site
tested on the ground
chosen by some of the largest
pharmaceutical companies for
their plants worldwide
4. system users
supervisor
checks qualification status
of his/her department
trainer
trains people: he/she is able
to prepare courses and
manage sessions
training office
central or departmental, has to
manage the system: the group is
enabled to use all the webTraining’s
functionalities, within its sphere of
responsibility
system administrator
creates profiles and users,
assigns access rights to
functions; checks audit-trail
trainee
he/she is able to do self-
enrollment, self-training and
self-exam
6. full featured and complete
training needs
definition /
planning /updating
training needs
detection
sessions
scheduling
training
delivery
training status
monitoring
7. definition of training needs
by specifying:
the role of each employee
the business activities (tasks) for each role
the training courses required to be qualified for each activity
analyst
Quality Control Blood Testing Trending
Documenting and Investigating …
Course . . . . . . . . . . . . .
Investigation and Retest …
Strip Sampling
Activity …
Results Trending
8. planning of complementary
trainings
easy, flexible and powerful management of
individual training plans
centralized general planning (coarse-grained)
distributed refinement (by supervisor)
monitoring of distributed planning activities
monitoring of execution against planned courses
comprehensive final certification
9. automatic detection of training
needs
for:
new employees and contractors
changes of role
addition of new activities
revision of procedures
re-training
and from individually planned courses
10. session management
courses preparation with complex training material
(PDF, PowerPoint, off-the-shelf
courseware, SCORM, Internet/Intranet sites, …)
and questionnaires
creation & management of training sessions
monitoring of training session status
electronic training notification/reminder, grouped
by recipient, through flexible scheduling system
and customizable texts
11. classroom / on-the-job self-service
flexible training delivery
downloading of training material
powerful results registration by
trainer
trainee’s e-signature
scanning of manually signed
training cards
on line self-enrollment
on line self-training
on line self-examination
automatic registration of training result
view/print own qualification against role’s
courses and training plan
12. paperless
every attendance has trainer’s and trainee’s e-
signature
backup functions for uploading of manually
signed documents
single access point to personal documents
(training cards, questionnaires, certificates,
etc.) system-generated or scanned
13. certification issuing
starting training package
individual training plan
periodic certification of individual
qualification
the process is repeatable for each new
activity assigned to the employee, thus
allowing reduction of training cycle time and
increase of productivity
14. rich reporting system
complete set of reporting features to:
monitor training status at all levels (individual,
department, site)
analyze amount of training hours, results, attended
courses, organizational and role changes, etc.
KPI on training gaps, training effectiveness
Business Intelligence module to create
instant and personalized analysis
17. standards-compliant
is in compliance with 21 CFR
part 11 rule:
electronic signature
recording for data changes
flexible access rights management
recording for accesses and not authorized
accesses management
audit-trail analysis
18. traceability
all the changes are tracked through the item
versioning:
role changes
activity changes
role revision
activity revision
course revision
the training status is available per any given time period
20. integration with eDMS
flexible support for complex issuing processes of new SOPs:
SOP pre-release training management with notification to
DMS of training result
new SOP or new edition when the training is not required
possibility to treat the SOP and related forms as unique
training object
capability to receive an electronic questionnaire from DMS,
approved together with the referred SOP
capability to treat small changes to SOPs without generating
training gaps
21. eDMS
Connector
Integration
Agent
webTraining
Database
webTRAINING
Application
webTRAINING
Integration Module
webTRAINING
Connectors
Integration
Queues
eDMS
eDMS
Database
Document
Management
1 - The Connector periodically
captures new documents from
eDMS …
2 - and copies them into Integration
Queues
3 - The Integration Agent reads new
document from Integration Queues …
4 - and creates related training object
and course
5 - Training Office member completes
course, selects trainees (from a list
provided by the system), organizes
training sessions, closes training on
new procedure
6 - The system generates a message
for the eDMS with the training result
9 - The eDMS promotes or withdraws
the procedure according to the
training result
7 - The Connector reads result from
Integration Queues …
8 - and passes it to eDMS
1
2
3
4
5
6
7
8
9
integration module
22. integration with MES
check for operator’s qualification at
Manufacturing Execution System login:
at material level
at equipment level
at procedures level
24. evolution and maintenance
activities governed by corporate methodology
guided by GAMP (Good Automated Manufacturing
Practice)
audited by some of the largest pharmaceutical
companies
ISO 9001:2008 certified
25. support
well defined SLA, procedures, reporting
dedicated team
specialized software for issues
management
27. 100% “21 cfr part 11
compliant”
100% web based
internationalized
installed on a single
central site for all
company’s plants
built on
enterprise level
architecture
full featured
paperless
easy to use